PATfix® pDNA Platform

Continued progress in gene therapy and DNA/RNA-based therapeutics has led to a growing demand for reliable pDNA production processes suitable for clinical applications. Increasing yield and purity in the production of pDNA is a vital step in meeting such demand.

The PATfix® pDNA platform provides valuable analytical insights at all stages of pDNA processing, from upstream production through downstream purification and from process development to production of materials for clinical or commercial applications. At-line analytics support informed, accelerated process development and secure production runs and product quality.

PATfix pDNA Platform in brief:

Fast, high-resolution HPLC analytics for in-process control of pDNA production and purification

• save time with rapid process development and optimization
• secure production runs with at-line feedback

Unique CIMac® pDNA analytical monolithic columns for isoform, multimer and impurity separation and quantification of both small and large plasmids

• simple sample prep, low sample consumption and short run times save time, labor and costs
• high content information allows informed decision-making

CFR Part 11 compliant PATfix® software provides easy data processing, visualization, presentation and sharing

• Access your data securely from anywhere with server-client based approach
• Single database of chromatograms from multiple runs and multiple systems
• Easily share interactive results with colleagues, customers and/or regulators
• Automated functions include A260/280 ration, peak normalization, 2° derivative, smoothing

The complete platform includes user guides, validated methods, SOPs, pDNA sc and oc calibration standards

• Direct start-up even for less experienced users, with easy to follow steps from buffer prep to report printing
• Fully optimized and validated analytical methods

Use PATfix pDNA for:

• separation of pDNA isoforms and multimers
• detection of process impurities, e.g. RNA, endotoxins, gDNAquantification and purity analysis of pDNA species
• pDNA process develoment, e.g. lysis condition optimization
• in-process control of pDNA production at all process stages
• batch-to-batch production and purification performance teacking
• monitoring of pDNA linearization for mRNA production
• product release and QA testing
• scale-down modelling of pDNA purification

PATfix® pDNA Platform Components

• PATfix® - Model-LPG (includes quaternary low pressure gradient pump with 10 mL pump head (ceramic), degasser, mixer (250 µL); eluent tray; MWD multi wavelength detector, 190 - 700 nm, 8 channel; uv flow cell: 10 mm, 10 µL; autosampler; conductivity | pH monitor; chromatography data system, single instrument license
• Column Oven
• PATfix® Software with pDNA Platform
• PATfix® pDNA user guides, validated analytical methods and SOPs
• pFix5 sc/oc pDNA standard for 20x calibrations
• Set of 5 CIMac® pDNA columns